Schizophrenia
Conditions
Interventions
investigational material(s)
Generic name etc : ME2112 capsule 40mg, ME2112 capsule 60mg
INN of investigational material : ziprasidone
Therapeutic category code : 117 Psychotropic agents
Dosage and Ad
Sponsors
Meiji Seika Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient with Schizophrenia as defined with DSM-IV-TR who meet all inclusion criteria and do not meet all exclusion criteria. - Patients with a PANSS total score between 50 and 120, inclusive, at the baseline visit - Patients who have been explained study objectives, methods and other aspects of study, and can give voluntary consent in writing
Exclusion criteria
Exclusion criteria: - Patients of treatment resistant schizophrenia - Patients with a primary active mental illness diagnosis other than schizophrenia - Patients with a history of significant cardiovascular disease - Patients with treated but uncontrolled hematological, hepatic, renal, respiratory, gastrointestinal, endocrine, or neurological diseases, or other clinically significant concomitant physical diseases - Patients who had received other investigational drugs within 90 days prior to baseline - Patients considered not to be eligible by the investigator etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events and Adverse drug reactions Incidence | — |
Secondary
| Measure | Time frame |
|---|---|
| PANSS Changes from baseline | — |
Outcome results
None listed